PD-1 Assay to Determine Atezolizumab Eligibility Receives FDA Approval for Use in NSCLC


The assay is meant to determine patient eligibility for atezolizumab, which was granted FDA approval in PD-L1-positive lung cancer on October, 15. The assay was used in the IMpower010 study.

The FDA has approved of the use of the VENTANA PD-1 Assay as a companion diagnostic test to determine which patients with non-small cell lung cancer (NSCLC) are eligible for atezolizumab (Tecentriq), according to a press release by Roche.1

Atezolizumab, which was approved on October 15, 2021, is meant for patients with PD-L1-positive NSCLC as adjuvant treatment following surgery and platinum-based chemotherapy. Currently, the standard of care in NSCLC is surgical resection of the tumor which may be followed by chemotherapy. However, approximately half of all patients relapse.

The assay was used as part of the Impower010 study (NCT02486718), which provided the data for atezolizumab’s approval in the PD-L1-postive NSCLC population. The parallel assignment, open-label study had an actual enrollment of 1280 participants. The primary end point of the study is disease-free survival (DFS). Secondary end points include overall survival, percentage of patients disease-free at 5 years, percentage of patients who experience and adverse event, the percentage of patients with anti-therapeutic antibodies to the study drug, maximum plasma concentration, and minimum serum concentration.2

All patients received 4, 21-day cycles of cisplatin-based chemotherapy, until unacceptable toxicity, disease relapse, or the patient decided to discontinue treatment. After the 4 cycles are complete, patients were randomized into 1 of 2 arms. In the experimental arm, patients received atezolizumab 1200 mg every 3 weeks for 16, 21-day cycles. Periodic chest x-rays were performed. In the control arm, patients received best supportive care with periodic chest X-rays.

At a median follow-up of 32.2 months, the 24-month DFS rate was 74.6% in the experimental arm compared with 60% in the control arm. AT 36-months, the DFS rate was 61% in the experimental arm and 48.2% in the control arm. In the experimental arm, the DFS rate was not evaluable (NE, 95% CI, 36.1%-NE) compared with 35.3 months (95% CI, 29.0-NE) in the control arm (stratified HR, 0.66; 95% CI, 0.50-0.88; P =.0004).3

In terms of safety, no new safety signals associated with atezolizumab were reported. In the experimental arm, 92.7% of patients experienced an AE compared with 70.7% of patients in the control arm. Grade 3/4 AEs were reported in 21.8% of patients in the experimental arm versus 11.5% in the control arm. Serious AEs were seen in 17.6% of patient. 

“Early detection of lung cancer can change the treatment pathway for patients and give them more treatment options,” said Thomas Schinecker, CEO Roche Diagnostics, in the press release. “We are proud to offer a companion diagnostic PD-L1 test that identifies lung cancer patients who may qualify for Tecentriq therapy. With the FDA approval of this companion diagnostic test, clinicians now have an effective tool for offering better patient care through targeted immunotherapy treatment.”

1.Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab). News release. Roche. October 22, 2021. Accessed October 22, 2021. https://bit.ly/3vzMfN1
2.Study to assess safety and efficacy of Atezolizumab (MPDL3280A) compared to best supportive care following chemotherapy in patients with lung cancer [IMpower010]. ClinicalTrials.gov. Accessed October 22, 2021. https://bit.ly/3C89gsT
3.Zhou C, Altorki N, Valliéres E, et al. IMpower010: A Phase III trial investigating atezolizumab (atezo) vs best supportive care (BSC) after adjuvant chemotherapy (chemo) in patients (pts) with completely resected NSCLC. Ann Oncol. 2016;26 (suppl 9): ix134-ix135. doi: 10.1093/annonc/mdw592
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